albuterol sulfate

Generic: albuterol sulfate

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler american health packaging
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 2.5 mg/3mL

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-395
Product ID 60687-395_199e7908-e7e3-15d7-e063-6294a90ad53f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077839
Listing Expiration 2026-12-31
Marketing Start 2019-01-11

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687395
Hyphenated Format 60687-395

Supplemental Identifiers

RxCUI
630208
UNII
021SEF3731

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name albuterol sulfate (source: ndc)
Generic Name albuterol sulfate (source: ndc)
Application Number ANDA077839 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/3mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (60687-395-83) / 1 AMPULE in 1 POUCH (60687-395-79) / 3 mL in 1 AMPULE
source: ndc

Packages (1)

60687-395-83 30 POUCH in 1 CARTON (60687-395-83) / 1 AMPULE in 1 POUCH (60687-395-79) / 3 mL in 1 AMPULE

Ingredients (1)

albuterol sulfate (2.5 mg/3mL)

Linked Drug Pages (1)

Albuterol Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "199e7908-e7e3-15d7-e063-6294a90ad53f", "openfda": {"unii": ["021SEF3731"], "rxcui": ["630208"], "spl_set_id": ["4aec7f59-b429-4b0e-a779-8df1dd8f80d7"], "manufacturer_name": ["American Health Packaging"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (60687-395-83)  / 1 AMPULE in 1 POUCH (60687-395-79)  / 3 mL in 1 AMPULE", "package_ndc": "60687-395-83", "marketing_start_date": "20190111"}], "brand_name": "Albuterol Sulfate", "product_id": "60687-395_199e7908-e7e3-15d7-e063-6294a90ad53f", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "60687-395", "generic_name": "Albuterol Sulfate", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2.5 mg/3mL"}], "application_number": "ANDA077839", "marketing_category": "ANDA", "marketing_start_date": "20190111", "listing_expiration_date": "20261231"}